Monday, March 30, 2009

Depression Tests Urged for Teenagers

An influential government-appointed medical panel is urging doctors to perform routine screening on all American teenagers for depression, a step that acknowledges that nearly two million teenagers are affected by this debilitating condition.

Most are undiagnosed and untreated, said the panel, the United States Preventive Services Task Force, which sets guidelines for doctors on a host of health issues.

The task force recommendations appear in the April issue of the journal Pediatrics. And they go further than the American Academy of Pediatrics’ own guidance for screening of teenage depression.

An estimated 6 percent of American teenagers are clinically depressed. Evidence shows that detailed but simple questionnaires can accurately diagnose depression in primary-care settings like a pediatrician’s office.

The task force said that when followed by treatment, including psychotherapy, screening can help improve symptoms and help children cope. Because depression can lead to persistent sadness, social isolation, school problems and even suicide, screening to treat it early is crucial, the panel said.

READ MORE @ NY TIMES

Sunday, March 29, 2009

Psychiatric Disorders Are Common In Adults Who Have Had Anorexia

The study was initiated in 1985. A total of 51 teenagers with anorexia nervosa were studied, together with an equally large control group of healthy persons. The groups have been investigated and compared several times as the years have passed.

"This study is unique in an international perspective. It is the only study in the world that reflects the natural course of anorexia nervosa in the population", says Elisabet Wentz, Associate Professor in Child and Adolescent Psychiatry at the Sahlgrenska Academy.

The research group has published new results from the study in two scientific journals: the British Journal of Psychiatry and the International Journal of Eating Disorders.

Three women have still not recovered from anorexia, 18 years after the start of the study. Thirteen people, or around 25%, are on disability benefit or have been signed off sick for more than six months due to an eating disorder or other psychiatric disorder.. Thirty-nine percent have at least one other psychiatric disorder, in addition to the eating disorder. The most common of these is obsessive compulsive disorder.

READ MORE @ SCIENCE DAILY

Friday, March 27, 2009

3 Researchers at Harvard Are Named in Subpoena

Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine.

The researchers — Drs. Joseph Biederman, Thomas Spencer and Timothy E. Wilens — are named in the subpoena, which was sent on Wednesday to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines.

READ MORE @ NY TIMES

Thursday, March 26, 2009

FDA Approves Olanzapine, Fluoxetine HCl for Treatment-Resistant Depression

The US Food and Drug Administration (FDA) has approved olanzapine and fluoxetine HCl (Symbyax) capsules for the indication of acute treatment of treatment-resistant depression (TRD) in adult patients who have not responded to 2 separate trials of different antidepressants of adequate dose and duration in their current episode.

An 8-week randomised, double-blind, controlled study evaluated the efficacy of olanzapine and fluoxetine HCl in patients (n=300) who met the fourth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD) and did not respond to 2 antidepressants of adequate dose and duration in their current episode.

READ MORE @ DOCTOR'S GUIDE

Wednesday, March 25, 2009

Inherited Depression Risk Linked to Brain Structure Abnormalities

Depression risk passed down through families may be due, in part, to structural thinning in a region of the brain that processes social and emotional stimuli, researchers said.

People with a family history of major depression had a 28% reduction in the thickness of gray matter in the right cerebral hemisphere compared to people with no known risk, Bradley Peterson, M.D., of the Columbia University Medical Center and New York State Psychiatric Institute, and colleagues found.

The effect was "remarkable for its magnitude and spatial extent," rivaling morphological abnormalities of the most severe neuropsychiatric disorders, including schizophrenia and Alzheimer's diseases, they reported online in the Proceedings of the National Academy of Sciences.

READ MORE @ MEDPAGE TODAY

Tuesday, March 24, 2009

Biomarkers of Illness and Treatment

Research on biological markers of disease process and treatment response were highlighted at the 48th annual New Clinical Drug Evaluation Unit meeting, “New Research Approaches for Mental Health Interventions,” convened by the NIMH, May 27-30 in Phoenix.

In a workshop on biomarkers, pharmacogenetics, and pharmacogenomics, Michael Henry, MD, of Caritas St Elizabeth’s Medical Center in Boston, indicated that technological improvements in scanner design, along with increasing understanding of neuropathophysiology, “offer an unprecedented opportunity for utilizing brain imaging techniques to improve the precision of clinical trials.”

Henry foresees the application of technologies such as MRI, PET, and single photon emission CT to reduce diagnostic variability in study populations, measure drug penetration of target sites, and establish biomarkers of therapeutic efficacy. Although imaging in clinical trials is most common in cardiology and oncology, Henry noted its recent use in trials of agents for dementia, depression, and psychosis.

Andrew Leon, PhD, of Weill Medical College of Cornell University, New York, agreed with the described potential of biomarkers to serve as primary end points in clinical trials but reminded conferees that the current status is either as secondary end points or “hypothesized moderators of outcome.” To go forward, he asserted, clinical trials will need to include validity testing of putative biomarkers.

READ MORE @ PSYCHIATRIC TIMES

Monday, March 23, 2009

FDA approves antidepressant Lexapro for adolescents

The decision comes after Justice Department allegations that the drug's maker, Forest Laboratories, had improperly induced pediatricians to prescribe it and a similar pill, Celexa.


Just weeks after prosecutors accused Forest Laboratories Inc. of illegally marketing its antidepressants Celexa and Lexapro to children and paying pediatricians kickbacks, U.S. health regulators Friday approved Lexapro for depression in kids.

Forest said Lexapro was approved by the U.S. Food and Drug Administration to treat major depressive disorder in adolescents aged 12 to 17 and as a maintenance therapy to control symptoms. It is already approved for adults, and registers annual sales of more than $2 billion.

The FDA on Friday approved Lexapro's use for adolescents based on favorable results in two clinical trials -- one involving adolescents taking Lexapro and another involving children and adolescents taking the chemically similar Celexa, Forest said.

READ MORE @ LOS ANGELES TIMES

Saturday, March 21, 2009

Older drug seen better for Parkinson's depression

People with Parkinson's disease who need treatment for depression seem to do better with an older antidepressant than a newer agent, according to a small clinical trial.

"Individuals with depression and Parkinson's disease do respond to antidepressants," Dr. Matthew Menza told Reuters Health. "This is important because depression in Parkinson's disease is often under-recognized, under-appreciated and under-treated. Commonly, the attitude is, 'of course you're depressed, you have a serious illness.' We have now demonstrated that one should be hopeful that treatment will help."

There have been few head-to-head trials of different antidepressants for Parkinson's patients with depression, Menza, of the Robert Wood Johnson Medical School in Piscataway, New Jersey, and his group note in the medical journal Neurology.

To investigate, they compared the older "tricyclic" antidepressant nortriptyline with the newer "SSRI" agent paroxetine in 52 people with Parkinson's disease diagnosed with major depression. Nortriptyline is available in generic form and under the brand name Pamelor, and paroxetine CR is known by the brand names Paxil and Seroxat.

READ MORE @ REUTERS

Friday, March 20, 2009

Risperdal Researcher Promised Drug Maker Positive Results from Clinical Trials

A prominent Harvard psychiatrist promised positive results to Johnson & Johnson before the start of some clinical trials for Risperdal. According to The Wall Street Journal, the revelations regarding Dr. Joseph Biederman came to light in court documents that are part of a lawsuit involving Risperdal and other atypical antipsychotic drugs. While he is not a defendant in the case, Biederman was called as a witness to illustrate the questionable financial ties between drug makers and the research community.

Some of the 2,000 plaintiffs involved in the multi-state lawsuit are children. Risperdal wasn’t approved for use in children until 2007. However, it is known that doctors prescribed the drug off-label for thousands of children years before that. While off-label prescribing is legal, drug companies are legally barred from marketing off-label uses. But according to The Boston Globe, the companies often skirt that prohibition by paying respected “opinion leaders” - usually top experts in their field - to discuss their off-label prescribing experiences at “educational” talks or meetings.

As we reported last November, Biederman was one of those opinion leaders. Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder. The lawsuit has raised questions about Biederman’s role in convincing Johnson & Johnson’s to fund a center on pediatric bipolar disorder at Harvard’s Massachusetts General Hospital.

READ MORE @ NEWS INFERNO

Thursday, March 19, 2009

Common Anticonvulsants May Raise Epileptics' Cardio Risk

Two widely prescribed anticonvulsants appear to increase cardiovascular risk in epileptics, researchers here found.

Patients who were switched from phenytoin or carbamazepine to newer medications had significant drops in cholesterol, C-reactive protein, and other markers of cardiovascular disease risk, Scott Mintzer, M.D., of Thomas Jefferson University here, and colleagues reported online in Annals of Neurology.

The researchers said it was unlikely the improvements resulted from treatment with the newer drugs.

"It's a consequence of being taken off the older ones, which were causing the cholesterol and other markers to be elevated in the first place," Dr. Mintzer said.

READ MORE @ MEDPAGE TODAY

Wednesday, March 18, 2009

Changing Rx Practices in the Treatment of Mental Illness: Impact on Forensic Evidence

"Off-label" prescription practices are increasingly used in the treatment of symptoms related to mental illness. In support of this conclusion, evidence is reviewed on the antidepressant treatment of numerous non-depressive disorders and on the antipsychotic drug treatment of non-psychotic disorders. The impact of this evidence is discussed in light of the Daubert decision rendered by the U.S. Supreme Court. It is concluded that such practices challenge the application of the decision and increase the potential for testimonial error. Finally, a promising trend of identifying drugs by their neurochemical action is briefly discussed.

One trend that has revolutionized the face of Clinical Psychopharmacology is a breakdown in the disorder-specific nature of drug treatment (i.e., the use of antidepressant drugs to treat depression, antipsychotic drugs to treat psychosis, etc.). This "off-label" prescription practice has resulted in a clear broadening of the range of possible psychological symptoms that can be positively influenced by a specific class of drugs. The purpose of this article is to present examples of this practice in the published literature and suggest how this trend has impacted forensic considerations in the area of Clinical Psychopharmacology. Although no attempt has been made to exhaust coverage of this trend, an attempt has been made to present examples representative of different classes of drugs.

READ MORE @ THE FORENSIC EXAMINER

Tuesday, March 17, 2009

Pitt Study Of Pregnant Women Shows Antidepressants, Depression May Raise Risk Of Premature Birth

Pregnant women who had untreated major depression in all three trimesters of pregnancy, as well as those who took certain antidepressants, had preterm birth rates exceeding 20 percent, according to a study by University of Pittsburgh School of Medicine researchers published in the March issue of American Journal of Psychiatry.

Approximately 10-to-20 percent of women struggle with symptoms of major depression during their pregnancies, but treating it can be complicated. Selective serotonin reuptake inhibitor (SSRI) antidepressants are usually the first line of depression treatment, but can lead to unwanted outcomes such as preterm births if used continuously throughout pregnancy, the findings suggest.

READ MORE @ MEDICAL NEWS TODAY

Monday, March 16, 2009

Antidepressants Linked to Sudden Cardiac Death in Women

A new study has concluded that women with no history of cardiac problems but who use antidepressants are at an increased risk for sudden cardiac death (SCD). HealthDay ,News reports that the reason for the link remains unknown, according to the researchers whose findings were published in the Journal of the American College of Cardiology.

“We suspect that their use is a marker for people with worse depression,” explained the study’s lead author Dr. William Whang, an assistant professor of clinical medicine at Columbia University Medical Center in Manhattan. “The elevated risk seems more specific for antidepressant use, but that use may well be a marker of more severe symptoms,” quoted HealthDay News. Whang noted that the link seemed to be physiological saying, “We found that women who had worse depressive symptoms had higher rates of risk factors such as hypertension, diabetes, and smoking.” As a matter-of-fact, the report indicated, said HealthDay News, women with clinical depression were at a two-fold risk of experiencing SCD.

READ MORE @ NEWS INFERNO

Tuesday, March 10, 2009

Aripiprazole Boosts Efficacy of Antidepressants in Older Patients With Major Depressive Disorder: Presented at AAGP

Adjunctive aripiprazole appears to be effective in relieving the symptoms of depression in patients aged 50 years or older, according to research presented at the American Association for Geriatric Psychiatry (AAGP) 22nd Annual Meeting.

J. Craig Nelson, MD, University of California San Francisco School of Medicine, San Francisco, California, and colleagues presented the findings here on March 6. According to the researchers, the treatment effect of selective serotonin-reuptake inhibitors is generally minimal in elderly patients with major depressive disorder. The current study sought to determine whether adjunctive aripiprazole might benefit this population when added to standard antidepressant treatment.

Aripiprazole is an atypical antipsychotic currently approved for use only as an adjunct to antidepressant medication.

READ MORE 2 DOCTOR'S GUIDE

Friday, March 6, 2009

Crackdown on Doctors Who Take Kickbacks

Federal health officials and prosecutors, frustrated that they have been unable to stop illegal kickbacks to doctors from drug and device companies, are investigating doctors who take money for using these products.

For years, prosecutors rarely pursued doctors because they believed that juries would sympathize with respected clinicians. But within a few months, officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products.

“What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it,” said Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services. “We want to send the message to the physician community — particularly surgeons — that you can’t do this.”

The move against doctors is part of a diverse campaign to curb industry marketing tactics that enrich doctors but increase health care costs and sometimes endanger patients. Taken together, the new measures are likely to transform the relationship between medicine and industry.

READ MORE @ NY TIMES

Thursday, March 5, 2009

Obama backing generic biologics

President Obama's budget would pave the way for government to approve generic versions of biologic drugs, an administration official said yesterday, a move that could save taxpayers, insurers, and patients billions on the world's most expensive drugs but could hurt profits of some Massachusetts biotechs.

The Food and Drug Administration currently has no process for approving biogenerics, also called "follow-on biologics" and "biosimilars." Such drugs are made from living organisms, not chemicals, and are extremely difficult to duplicate precisely. Congress in the last few years has haggled over how to create regulations to approve generic versions of biologics.

The generic industry has proposed letting companies copy biologics after three to five years, similar to rules set for conventional drugs under the 1984 Hatch-Waxman Act. The administration's proposal suggests the time frame would be consistent with Hatch-Waxman, though administration officials could not confirm that last night.

READ MORE @ BOSTON GLOBE

Wednesday, March 4, 2009

How to Get Off Psychiatric Drugs Safely

Taper off antidepressants, antipsychotics, benzodiazepines and ADHD Medication without withdrawal side. The new fourth edition book "How to Get Off Psychiatric Drugs Safely" by James Harper, researcher and founder of The Road Back Program, details a proven successful method for tapering off these medications with separate chapters covering each of several classes of drugs.

Millions suffering the myriad side effects caused by antidepressants, benzodiazepines, antipsychotics and ADHD medications - from extreme weight gain to a dulled life - want to stop taking the drugs, their doctors would like to have their patients off the drugs, but cannot endure the emotional and physical pain involved with withdrawal or by what is known as discontinuance syndrome. Drug companies now state in the drug descriptions the medications must be tapered off of slowly to help avoid this debilitating withdrawal syndrome. The common withdrawal side effects include; electric brain zaps, nausea, anxiety, strange behavior, insomnia even relapsing into conditions these drugs are supposed to address.

The new fourth edition book "How to Get Off Psychiatric Drugs Safely" by James Harper, researcher and founder of The Road Back Program, details a proven successful method for tapering off these medications with separate chapters covering each of several classes of drugs, from antidepressants, antipsychotics, anti-anxiety medications to ADHD drugs and benzodiazepines. Employing specific vitamins and nutritional supplements, this exact tapering method has been successfully used by more than 30,000 people and is endorsed by doctors across the US, as well as the UK and Europe.

READ MORE @ PR WEB

Tuesday, March 3, 2009

Mental illness 'link to parents'

Children of bipolar parents have a 13-fold increased chance of suffering the same problem or other psychiatric disorders themselves, a study has shown.

A team of psychiatrists assessed two groups of children aged six to 18 for signs of bipolar disorder - formally known as manic depression - or other problems such as mood or anxiety disorders.

One group of 388 children had mothers or fathers with bipolar disorder. The other group of 251 had parents with no mental health problems.

A total of 10.6% of children with bipolar parents were positively tested for bipolar disorder or mood and anxiety disorders. In comparison, just 0.8% of children of mentally healthy parents had psychiatric conditions.

READ MORE @ PRESS ASSOCIATION

Sunday, March 1, 2009

AstraZeneca Seroquel Studies ‘Buried,’ Papers Show (Update3)

AstraZeneca Plc “buried” unfavorable studies on its antipsychotic drug Seroquel, according to an internal e-mail unsealed as part of litigation over the medicine.

The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in “cherry picking” of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients. The London-based company faces about 9,000 lawsuits claiming it failed to properly warn users that Seroquel can cause diabetes and other health problems.

“The larger issue is how we face the outside world when they begin to criticize us for suppressing data,” John Tumas, an AstraZeneca publications manager, told colleagues in the e-mail.

READ MORE @ BLOOMBERG